It was recently reported that the massively hyped microbicide gel that might reduce HIV transmission from men to women by 39% failed to attract enough funding to run further trials. They had only managed to raise $40 million of the $100 million they needed.
Well now it's back, they hype, that is. The funding is not mentioned, though I assume it has been raised. I wrote two posts about this issue a few months ago. The first was about how unconvincing the whole trial was, along with the media coverage it received. The second was about how the trial was likely to be both invalid and unethical.
None of the worries that I and others have expressed about the trial, known as CAPRISA, have been answered by any subsequent publications. But now the gel has been 'fast-tracked' by the FDA.
The most worrying statement in this article about the 'fast-tracking' is: "most new cases are among women infected during sex with men". Most new cases are among women, but there is little evidence that most of them result from sex with men.
The CAPRISA trial itself gives numerous indications that HIV is not spread solely by sex. Most of the participants didn't engage in much sex and most of them used condoms most of the time. In other words, the sex involved was not predominantly 'unsafe' sex. But, despite this, HIV transmission rates were appallingly high. Why? The trial did not attempt to establish why.
This trial was indifferent as to whether people were infected sexually or non-sexually. Data about how many male partners were HIV positive, and how many had the same viral strain as their female partner, were not collected.
The assumption that HIV is almost always transmitted sexually (in African countries, not in non-African countries) informs most HIV prevention programming. Evidence of non-sexually transmitted HIV is often ignored or even suppressed. It is never investigated.
But even though the CAPRISA trial demonstrated the irrelevance of sexual behavior in very high transmission scenarios, apparently trials are going to continue. Worse still, all sorts of plans are being made about commercial production of the gel, as if its effectiveness has been demonstrated!
Almost all the money currently being spent on HIV prevention (as opposed to treatment, which receives far more funding) goes to programs that assume that sex is the problem. The result is that hardly any money goes into preventing HIV transmission that doesn't result from sex. Yet, medical services in African countries are of such low quality that UNAIDS warns UN employees about the risk of being infected with HIV from medical treatment.
If there are risks of medical transmission of HIV for UN employees, there are medical risks for everyone. The refusal of the CAPRISA trial to warn participants about non-sexual risks renders the trial unethical. The failure to investigate how participants were infected renders it invalid. This vaginal gel is just one more travesty being committed by the HIV industry.
(For discussion of pre-exposure prophylaxis (PrEP), see my other blog.)
Showing posts with label rights here right now. Show all posts
Showing posts with label rights here right now. Show all posts
Wednesday, October 27, 2010
Friday, July 23, 2010
How Convinced Were You by the Microbicide Story?
The six day Vienna Aids Conference has come to an end and the freeloaders will have to finish up their last free drinks until the next junket. The press has excelled itself by repeating, almost word for word, everything they were told to publish. Searches for any of the conference catch phrases, such as 'Treatment 2.0', 'treatment as (or 'is') prevention', 'rights here, right now' or 'Tenofovir gel', etc, will yield thousands of results, all equally uninformative.
Outside the mainstream press, the Huffington Post has an article that questions the big story of the week, the announcement that a vaginal gel, using the antiretroviral drug Tenofovir, has shown some promise in trials. The author, John R Talbott, points out that the results are not really as exciting as they seem and that using this gel will only give a relatively small amount of protection. Over a lifetime, the majority of people in a population like the one in the trial will still eventually become infected, even if they use the gel all the time.
The paper entitled 'Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women' is indeed very unconvincing. Even the authors must feel pretty uncomfortable about the results of their trial and the many unanswered questions thrown up. In the introduction, they mention that in the past three decades "Only five of 37 randomized controlled trials, which tested 39 HIV prevention strategies, have demonstrated protection against sexual transmission of HIV infection". Three of the five are circumcision trials, which were well publicized but not very encouraging. The fourth was a vaccine in Thailand, which was also disappointing.
The fifth was a sexually transmitted infection (STI) treatment trial in Tanzania. Similar trials were carried out in other locations at the same time but they didn't result in any reduction in HIV transmission. The trial in Tanzania seemed to, except that there was an injection safety trial going on at the same time in the same place. It is highly likely that this affected the results of the STI trial. Yet, even though those working on it knew about the injection safety trial, they failed to mention it until many years after publishing their initial results.
The history of HIV prevention is notable not so much for its failures as for the way those failures have been dressed up as successes. The Vienna Conference has pushed the Tenofovir gel trial as a great breakthrough and the press have bounced the story around the world (and the www). The authors of the paper may well be regretting that their work has been chosen to be hyped above all others this time around. They, of all people, are probably painfully aware that we are still a long way from a pharmaceutical product that will have a significant impact on HIV transmission.
The trial itself is quite tentative, involving a small number of people. And the scope of the research was very narrow. One of the most shocking things is how high incidence is, in both the intervention (5.6%) and the control (9.1%) groups. If you had hundreds of people whose sexual behavior you were studying, you might want to investigate their sexual behavior. This trial didn't really do that. They didn't test the participants' partners. They don't even know if those who contracted HIV did so through sexual behavior! Or, if they did check the partners, they don't mention this in the paper.
Another extraordinary thing about the trial is that condom use was high and steady throughout the trial, in both intervention and control groups. Condom manufacturers must be wondering exactly what the participants did with the condoms to have such poor results with them.
Over the trial period, the number of sex acts involved was not particularly high. Even if none of the participants had used condoms, incidence of between 5.6 and 9.1% would be hard to explain. The authors speculate about the women having sex with 'migrant workers' but they don't say if the women did so. The trial selected women that were at low risk of being infected with HIV, so why did so many turn out to be at high risk?
Not only did the women in the trial not have sex particularly often but they had sex less and less often as the trial went on. The number of sex acts per month went from 7.2 to 3.1 per month. The more people were having sex, the less likely they were to use the gel and those who were having sex least frequently were the most likely to use the gel. But frequency of sex doesn't seem to change the risk of becoming infected. It's as if sexual behavior is not especially relevant to the results of the trial.
Talbott touts his own theory of why HIV rates are so high in Africa. He concludes that it is because of the "numerous and informal sexual affairs common in Southern African nations, found both among married and unmarried men, especially with a much smaller highly infected group of very sexually active women who trade sexual favors for material goods and money". There is, in fact, no evidence that 'Southern Africans' have more 'informal sexual affairs' than many people in other continents (or countries). But the Tenofovir trial itself even finds that sexual behavior is not very frequent. Nor does it appear to involve a lot of 'unsafe' sex.
And, like many people who rush to such conclusions, Talbott also doesn't explain how large groups of sexually promiscuous men and small groups of sexually promiscuous women can give rise to far more women being infected than men. Perhaps he would, along with others, say that all these men go home and infect their wives. But about half of the HIV positive married women have HIV negative husbands. His argument suggests, as all arguments do that try to explain high HIV prevalence by reference to sexual behavior alone, that Africans have a lot more unsafe sex than non-Africans and that many of the women are exceptionally promiscuous.
Firstly, we know that Africans don't have a lot more unsafe sex than non-Africans, secondly, we know that African women are not exceptionally promiscuous and thirdly, it has also been shown that even very high rates of unsafe sexual behavior do not explain the levels of HIV prevalence found in some African countries. I applaud Talbott for criticizing the dubious claims being made about the Tenofovir gel trials. But he doesn't do much for his credibility, or that of the Huffington Post, by falling back on the racist and sexist views of the HIV industry.
Talbott calls for testing. What is needed is investigation. Why are so many women whose lifestyle is not risky becoming infected with a virus that is difficult to transmit? Why were their partners not tested, or if they were, why were the results not published? Who cares whether the gel works or not when we don't even know how the women were becoming infected? Like all the other 'major breakthroughs' discussed at the conference, this gel will only be useful if HIV is mostly sexually transmitted. This is far from evident.
Outside the mainstream press, the Huffington Post has an article that questions the big story of the week, the announcement that a vaginal gel, using the antiretroviral drug Tenofovir, has shown some promise in trials. The author, John R Talbott, points out that the results are not really as exciting as they seem and that using this gel will only give a relatively small amount of protection. Over a lifetime, the majority of people in a population like the one in the trial will still eventually become infected, even if they use the gel all the time.
The paper entitled 'Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women' is indeed very unconvincing. Even the authors must feel pretty uncomfortable about the results of their trial and the many unanswered questions thrown up. In the introduction, they mention that in the past three decades "Only five of 37 randomized controlled trials, which tested 39 HIV prevention strategies, have demonstrated protection against sexual transmission of HIV infection". Three of the five are circumcision trials, which were well publicized but not very encouraging. The fourth was a vaccine in Thailand, which was also disappointing.
The fifth was a sexually transmitted infection (STI) treatment trial in Tanzania. Similar trials were carried out in other locations at the same time but they didn't result in any reduction in HIV transmission. The trial in Tanzania seemed to, except that there was an injection safety trial going on at the same time in the same place. It is highly likely that this affected the results of the STI trial. Yet, even though those working on it knew about the injection safety trial, they failed to mention it until many years after publishing their initial results.
The history of HIV prevention is notable not so much for its failures as for the way those failures have been dressed up as successes. The Vienna Conference has pushed the Tenofovir gel trial as a great breakthrough and the press have bounced the story around the world (and the www). The authors of the paper may well be regretting that their work has been chosen to be hyped above all others this time around. They, of all people, are probably painfully aware that we are still a long way from a pharmaceutical product that will have a significant impact on HIV transmission.
The trial itself is quite tentative, involving a small number of people. And the scope of the research was very narrow. One of the most shocking things is how high incidence is, in both the intervention (5.6%) and the control (9.1%) groups. If you had hundreds of people whose sexual behavior you were studying, you might want to investigate their sexual behavior. This trial didn't really do that. They didn't test the participants' partners. They don't even know if those who contracted HIV did so through sexual behavior! Or, if they did check the partners, they don't mention this in the paper.
Another extraordinary thing about the trial is that condom use was high and steady throughout the trial, in both intervention and control groups. Condom manufacturers must be wondering exactly what the participants did with the condoms to have such poor results with them.
Over the trial period, the number of sex acts involved was not particularly high. Even if none of the participants had used condoms, incidence of between 5.6 and 9.1% would be hard to explain. The authors speculate about the women having sex with 'migrant workers' but they don't say if the women did so. The trial selected women that were at low risk of being infected with HIV, so why did so many turn out to be at high risk?
Not only did the women in the trial not have sex particularly often but they had sex less and less often as the trial went on. The number of sex acts per month went from 7.2 to 3.1 per month. The more people were having sex, the less likely they were to use the gel and those who were having sex least frequently were the most likely to use the gel. But frequency of sex doesn't seem to change the risk of becoming infected. It's as if sexual behavior is not especially relevant to the results of the trial.
Talbott touts his own theory of why HIV rates are so high in Africa. He concludes that it is because of the "numerous and informal sexual affairs common in Southern African nations, found both among married and unmarried men, especially with a much smaller highly infected group of very sexually active women who trade sexual favors for material goods and money". There is, in fact, no evidence that 'Southern Africans' have more 'informal sexual affairs' than many people in other continents (or countries). But the Tenofovir trial itself even finds that sexual behavior is not very frequent. Nor does it appear to involve a lot of 'unsafe' sex.
And, like many people who rush to such conclusions, Talbott also doesn't explain how large groups of sexually promiscuous men and small groups of sexually promiscuous women can give rise to far more women being infected than men. Perhaps he would, along with others, say that all these men go home and infect their wives. But about half of the HIV positive married women have HIV negative husbands. His argument suggests, as all arguments do that try to explain high HIV prevalence by reference to sexual behavior alone, that Africans have a lot more unsafe sex than non-Africans and that many of the women are exceptionally promiscuous.
Firstly, we know that Africans don't have a lot more unsafe sex than non-Africans, secondly, we know that African women are not exceptionally promiscuous and thirdly, it has also been shown that even very high rates of unsafe sexual behavior do not explain the levels of HIV prevalence found in some African countries. I applaud Talbott for criticizing the dubious claims being made about the Tenofovir gel trials. But he doesn't do much for his credibility, or that of the Huffington Post, by falling back on the racist and sexist views of the HIV industry.
Talbott calls for testing. What is needed is investigation. Why are so many women whose lifestyle is not risky becoming infected with a virus that is difficult to transmit? Why were their partners not tested, or if they were, why were the results not published? Who cares whether the gel works or not when we don't even know how the women were becoming infected? Like all the other 'major breakthroughs' discussed at the conference, this gel will only be useful if HIV is mostly sexually transmitted. This is far from evident.
Thursday, July 22, 2010
Sniff it, Lick it, Publish it
If someone at the Vienna Aids Conference put out a press release saying tests have shown that regular use of bouncy castles cures HIV, would the world's media repeat it, just as they have done with every other improbable press release that has come out over the past few days? Have these journalists ever heard of criticism, originality, judgment, analysis or even writing? They did the same during the World Cup, regurgitating every scrap of rubbish they could find. Was everything washed down with free beer (Fifa approved, of course)? If so, no doubt they are washing things down with good wine in Vienna.
Even Reuters' AlertNet follows the flock with their triumphalist 'MTV drama brings cool to HIV prevention'. Apparently this drama, 'Shuga', was aired some time last year, but where? Perhaps it was aired in Nairobi or in private schools but I don't know anyone who has seen it or even heard of it. "In Kenya, the drama was watched by an astonishing 60 percent of young people – those are amazing figures for any programme," Bill Roedy, CEO of MTV, told IRIN/PlusNews. They're not just amazing, they are not credible. Where's the evidence, Roedy?
Over 80% of Kenyans live in rural areas and about 70% of those who live in urban areas live in slums. Official figures claim that only about 30% of Kenyans do not have access to electricity and that only about 25% don't have regular access to the media (print, radio and TV). But how many people have TVs or regular access to TVs? Most people in the areas I've been working in don't. But in the euphoria at Vienna, with the desperation to churn out feel-good stories, the press will repeat anything they are fed. Haven't they ever heard of evidence?
As for the 'evaluation' of what people learned and think and what that might show, what does that mean? Most people visit the bathroom after watching a few TV shows, does that mean they are good laxatives? Of course young people will be able to repeat what they have heard, especially when treated to a TV show about sex (though I'm still wondering how many have really seen it). Children here, and adults, have been blasted with rubbish about HIV and sex for so long now they know exactly what to say when asked. The problem is, even people who work with HIV have no idea that HIV can be and is transmitted non-sexually, nor any idea how to protect themselves from non-sexual HIV transmission.
This is an extremely dangerous situation. I've sat with people and discussed conditions in hospitals, their experiences with doctors, nurses, dentists and others who might pose a risk of blood-borne infection of some kind. But when the conversation turns to HIV risk reduction, they always talk about sexually transmitted HIV. Of course, Shuga is about sexually transmitted HIV, from what I can glean. What else is there, if you're part of the mainstream media, which MTV most certainly is.
Contradictions are not considered important in the HIV industry but one of the feel-good stories that's been churned around before and during the conference has been about young people 'leading' the drop in the spread of HIV. Yet now, the AlertNet article says "Worldwide, 40 percent of new HIV infections occur among young people between the ages of 15 and 24. Behaviour change campaigns have shown some success...". Behaviour change campaigns have resulted in people being able to answer questions about things they have been taught but they have not resulted in significant levels of behaviour change. And they have had no impact whatsoever on HIV transmission rates.
The 'evaluation' was carried out by the Johns Hopkins Centre for Communication Programs. Johns Hopkins, like the HIV industry, is vehemently opposed to the idea that HIV is commonly transmitted non-sexually in African countries. But just because the HIV industry is completely biased against anything that could threaten their massive levels of funding, that doesn't mean the media should behave as the lapdog of industry, academia and anyone else handing out free booze (or whatever they get out of it).
There's no polite way to say this and politeness would be misplaced anyway: the Vienna Aids Conference is an (expensive) exercise in arse sniffing, a specialty of the press. One can only wonder what they all do to while away the time during those long presentations and seminars. When I tell people in rural areas about things like the HIV industry and conferences, they ask reasonable questions, such as 'what is HIV prevalence like in Vienna?', 'why are they there?', 'how expensive are these conferences?' and 'if the industry gets so much money, why does none of it end up here?' Any chance of a woof, a yelp or even a whimper from the pampered, or they too well bred?
Even Reuters' AlertNet follows the flock with their triumphalist 'MTV drama brings cool to HIV prevention'. Apparently this drama, 'Shuga', was aired some time last year, but where? Perhaps it was aired in Nairobi or in private schools but I don't know anyone who has seen it or even heard of it. "In Kenya, the drama was watched by an astonishing 60 percent of young people – those are amazing figures for any programme," Bill Roedy, CEO of MTV, told IRIN/PlusNews. They're not just amazing, they are not credible. Where's the evidence, Roedy?
Over 80% of Kenyans live in rural areas and about 70% of those who live in urban areas live in slums. Official figures claim that only about 30% of Kenyans do not have access to electricity and that only about 25% don't have regular access to the media (print, radio and TV). But how many people have TVs or regular access to TVs? Most people in the areas I've been working in don't. But in the euphoria at Vienna, with the desperation to churn out feel-good stories, the press will repeat anything they are fed. Haven't they ever heard of evidence?
As for the 'evaluation' of what people learned and think and what that might show, what does that mean? Most people visit the bathroom after watching a few TV shows, does that mean they are good laxatives? Of course young people will be able to repeat what they have heard, especially when treated to a TV show about sex (though I'm still wondering how many have really seen it). Children here, and adults, have been blasted with rubbish about HIV and sex for so long now they know exactly what to say when asked. The problem is, even people who work with HIV have no idea that HIV can be and is transmitted non-sexually, nor any idea how to protect themselves from non-sexual HIV transmission.
This is an extremely dangerous situation. I've sat with people and discussed conditions in hospitals, their experiences with doctors, nurses, dentists and others who might pose a risk of blood-borne infection of some kind. But when the conversation turns to HIV risk reduction, they always talk about sexually transmitted HIV. Of course, Shuga is about sexually transmitted HIV, from what I can glean. What else is there, if you're part of the mainstream media, which MTV most certainly is.
Contradictions are not considered important in the HIV industry but one of the feel-good stories that's been churned around before and during the conference has been about young people 'leading' the drop in the spread of HIV. Yet now, the AlertNet article says "Worldwide, 40 percent of new HIV infections occur among young people between the ages of 15 and 24. Behaviour change campaigns have shown some success...". Behaviour change campaigns have resulted in people being able to answer questions about things they have been taught but they have not resulted in significant levels of behaviour change. And they have had no impact whatsoever on HIV transmission rates.
The 'evaluation' was carried out by the Johns Hopkins Centre for Communication Programs. Johns Hopkins, like the HIV industry, is vehemently opposed to the idea that HIV is commonly transmitted non-sexually in African countries. But just because the HIV industry is completely biased against anything that could threaten their massive levels of funding, that doesn't mean the media should behave as the lapdog of industry, academia and anyone else handing out free booze (or whatever they get out of it).
There's no polite way to say this and politeness would be misplaced anyway: the Vienna Aids Conference is an (expensive) exercise in arse sniffing, a specialty of the press. One can only wonder what they all do to while away the time during those long presentations and seminars. When I tell people in rural areas about things like the HIV industry and conferences, they ask reasonable questions, such as 'what is HIV prevalence like in Vienna?', 'why are they there?', 'how expensive are these conferences?' and 'if the industry gets so much money, why does none of it end up here?' Any chance of a woof, a yelp or even a whimper from the pampered, or they too well bred?
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